- Determine the therapeutic response to this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study of fenretinide.

Patients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours
followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive
fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses
in the absence of disease progression or unacceptable toxicity. Patients who achieve
complete response receive 2 additional courses.

Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1 year.

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